Page 2 MediMark Europe Sarl 11 rue Emile ZOLA, B.P. 2332, 38033 Grenoble Cedex 2 France 0086 For EU Customers: All products at the end of their life may be returned to ImpediMed for recycling. For patent(s) and/or patent application(s) see: https://www.impedimed.com/patents/ ©...
Page 3: Table Of Contents
1.1.2 SOZOapp ..............................8 1.2 User Devices ..........................8 1.3 MySOZO ........................... 8 2.0 Glossary ......................... 10 3.0 Introduction to the SOZO System ................... 14 3.1 Bioimpedance Spectroscopy (BIS) ................... 14 3.2 SOZO System Overview ......................15 3.3 The SOZO Device ........................16 3.3.1 SOZO Device Hardware Components ......................
Page 4 5.1.2.9 Step Nine: Attach SOZOcradle to SOZOtouch ..................30 5.2 SOZO Device without SOZOsupport Stand ................31 5.2.1 Attach SOZOtouch to SOZOstep with SOZOconnect Cable ................ 31 5.2.2 Connect SOZOcradle ..........................32 5.2.3 Connect Power Supply ..........................32 6.0 MySOZO ........................33 6.1 Introduction ...........................
Page 5 8.0 Using the SOZOapp ......................83 8.1 Introduction ........................... 83 8.2 Start-Up ..........................83 8.2.1 Pairing the Tablet with the SOZO Device ....................83 8.4 Selecting SOZO Device ......................85 8.2.2 Tap SOZOapp ............................. 85 8.2.3 Enter Email Address ..........................85 8.3 SOZOapp Home Screen ......................
Page 6 10.1.3.1 Error Message ..........................134 10.1.3.2 Resolution ............................134 10.1.4 Losing Connectivity During Measurement ................... 135 10.1.3.4.1 Error Message ..........................135 10.1.3.4.2 Resolution ........................... 135 10.2 General Troubleshooting Chart ................... 135 © ImpediMed – April 2019 Page 6 LBL-537-en REV B...
Page 7 11.0 Personal Data ......................140 12.0 Care and Maintenance ....................141 12.1 The SOZO Device ........................ 141 12.1.1 Care ................................ 141 12.1.2 Maintenance ............................141 12.2 Self-Test ..........................141 12.3 Repairs ..........................142 12.4 Tablet Maintenance......................142 12.5 Technical Support ....................... 142 12.6 Components and Accessories ....................
Page 8: Minimum Requirements
SOZO Device. 1.1.1 Tablet Function The Tablet is the primary user interface for the SOZO Device. Clinicians use the Tablet for all SOZO functions, including management of patient profiles, and the entry of patient measurements and data for SOZO Assessments. For product details on the Tablet, review www.samsung.com...
Page 9 MySOZO Minimum and Recommended Requirements Component Requirements Internet Speed Minimum>15 Mbps download, 5 Mbps/ upload Recommended>25Mbps download, 5 Mbps upload Web Browser Google Chrome, Mozilla Firefox © ImpediMed – April 2019 Page 9 LBL-537-en REV B...
Page 10: Glossary
2.0.11 Clinic-A customer of ImpediMed, such as a hospital or medical facility, which uses the SOZO system. 2.0.12 Clinician -The primary User of the SOZO system, and an authorized User of MySOZO and the SOZOapp. The Clinician uses the SOZO Device to: take and record measurements of patients;...
Page 11 2.0.21 Fluid Analysis Assessment- Also referred to as “Fluid Analysis,” the Fluid Analysis Assessment is performed by the SOZO Device of certain fluid levels of patients living with heart failure. Indications for Use and Instructions for Use of the Fluid Analysis...
Page 12 L-Dex values, derived from the ratio of impedance for the unaffected limb and the at-risk limb, of the body fluid levels of patients at risk of lymphoedema, using certain patient measurements taken with the SOZO Device. Indications for Use and Instructions for Use ®...
Page 13 (places their feet) for connection to the SOZO Device. 2.0.50 SOZO system-The commercially available medical device system manufactured by ImpediMed, also referred to as the SOZO Digital Health Platform in the SOZOapp, which uses Bioimpedance Spectroscopy to perform various Assessments of patient fluid levels.
Page 14: Introduction To The Sozo System
3.0 Introduction to the SOZO System The SOZO system is a medical device system comprised of hardware and software. The SOZO system hardware components are the SOZO Device and the Tablet. SOZO system software is made up of the SOZOapp and MySOZO. Users may access the SOZO system through the SOZOapp on the Tablet, or by the internet through MySOZO.com.
Page 16: The Sozo Device
It may also be used to monitor fluid levels in patients living with heart failure. The SOZO system may be an integral part of a treatment plan for a lymphoedema and heart failure patient. Using the SOZO system, a Clinician may also monitor patient progress, including using the establishment of a baseline to track patient historical measurements.
Page 17: Sozo Device Hardware Components
3.3.1 SOZO Device Hardware Components The SOZO Device has the hardware components shown below. (1) SOZOsupport Stand (2) SOZOtouch (3) Handplate (4) SOZOstep (5) Footplate (6) Power Adaptor and Power Cord (7) SOZOconnect Cable (8) SOZOcradle (9) Tablet (10) Screws and Hex Key for SOZOsupport Stand ©...
Page 18: Assessment Licences
5.1.2 Assembly Process. 3.4 Assessment Licences Clinicians use the SOZO system to perform measurements and Assessments on patients As an ImpediMed customer, a Clinic must purchase a separate licence for each Assessment. A Clinic may purchase a licence to use one, some, or all Assessments offered in their geographic region by ImpediMed, depending upon the needs of the Clinic and its patients.
Page 19: Safety Instructions
Follow instructions for use. Note For EU Customers: All products at the end of their life may be returned to ImpediMed for recycling. This device is rated BF as per IEC60601-1. This device meets the standard IEC60601-1-2. This is a Class 2 medical device.
Page 20: Intended Use
SOZO Device. The SOZO Device is a medical device intended for clinical use by operators who have read this User Guide. The SOZO Device is intended for use, under the direction of the operator, for the non-invasive monitoring and management of fluid levels in patients.
Page 21 Only use the Power Adaptor supplied with the SOZO Device. The use of any other Power Adaptor may expose the patient to the risk of electrocution. Do not use or operate the SOZO Device in the presence of strong electromagnetic fields. This Medical Device may interfere with other Medical Devices in its vicinity.
Page 22: Use And Storage Conditions
Ensure that all data collected from the SOZO Device is assessed under supervision of a physician when managing a chronic disease The SOZO Device has a maximum weight capacity of 170 kg (375 lbs). Do not use the SOZO Device in a standing position if patient weight exceeds 170 kg (375 lbs).
Page 23: Location For Use
4.7 Location for Use When used with the stand accessory, the SOZO Device should be placed on a flat, stable surface near a standard power outlet, with room on either side to allow free access to the electrodes. If the system is configured for seated use, place at a non-metal desk that allows comfortable access from a seated position to the SOZOstep and SOZOtouch components.
Page 24: Sozo Device Assembly
5.0 SOZO Device Assembly 5.1 SOZO Device with SOZOsupport Stand Most patients stand during measurement, which requires assembly of the SOZO Device with the SOZOsupport Stand. Follow these steps to assemble the SOZO Device with the SOZOsupport Stand. 5.1.1 Identify SOZO Device Components Before assembly, identify the SOZO Device components shown below.
Page 25: Assembly Process
SOZOsupport Stand, the first person attaches the Footplate using the Hex Key. 5.1.2.2 Step Two: Attach Handplate to SOZOsupport Stand Screw the Handplate into the top of the SOZOsupport Stand. © ImpediMed – April 2019 Page 25 LBL-537-en REV B...
Page 26 Once the Footplate and Handplate are connected to the SOZOsupport Stand, the large drop hole should be near the top opposite of the blue stripe as shown in Step Three. © ImpediMed – April 2019 Page 26 LBL-537-en REV B...
Page 27: Step Three: Lace Sozoconnect Cable Through Sozosupport Stand
Feed the SOZOconnect Cable out of the front hole at the base of the SOZOsupport Stand. Either end of the SOZOconnect Cable may be used to connect the SOZOtouch and SOZOstep. © ImpediMed – April 2019 Page 27 LBL-537-en REV B...
Page 28: Step Four: Attach Sozotouch To Handplate
SOZOtouch. 5.1.2.6 Step Six: Attach SOZOconnect Cable to SOZOstep Make sure that the screw on the SOZOconnect Cable is facing upwards before attaching it to the SOZOstep. © ImpediMed – April 2019 Page 28 LBL-537-en REV B...
Page 29: Step Seven: Connect Power Cord To Sozostep
SOZOstep. Feed the corresponding end of the Power Cord through the openings in the bottom of the SOZOsupport Stand and connect it to the port. Before using the SOZO Device for the first time, make sure to follow all steps for start-up of MySOZO in Section 6.2.1 First Time Set-Up and the SOZOapp,...
Page 30: Step Eight: Attach Sozostep To The Footplate
Once the SOZOstep is in place, plug the Power Cord into the wall outlet. 5.1.2.9 Step Nine: Attach SOZOcradle to SOZOtouch Once the SOZOcradle is secure, place the Tablet in a landscape position on the SOZOcradle © ImpediMed – April 2019 Page 30 LBL-537-en REV B...
Page 31: Sozo Device Without Sozosupport Stand
ImpediMed technical support, per Section 12.5 Technical Support. 5.2 SOZO Device without SOZOsupport Stand To use the SOZO Device while the patient is sitting, follow the instructions for use in Section 7.2.3 Seated Position. Sometimes, a patient is unable to stand during measurement. In that case, follow the steps below to assemble the SOZO Device without the SOZOsupport Stand.
Page 32: Connect Sozocradle
SOZO Device may be safely turned off by unplugging the Power Adaptor. Only use the Power Adaptor that is supplied with the SOZO Device. The use of any other Power Adaptor may expose the patient to the risk of electric shock.
Page 33: Mysozo
6.0 MySOZO MySOZO allows the User to access the SOZO system from any User Device with internet access, provided that the User Device has a Google Chrome or Mozilla Firefox web browser. Section1.3 MySOZO Minimum Requirements. MySOZO is accessed through a web portal, MySOZO.com. SOZO accounts and patient data, including patient measurement data and Assessment results, may be viewed in MySOZO.
Page 34: Set New Password
Temporary Password that was provided in the email and sets and confirms a new password and clicks Submit. 6.2.1.3 User Password Privacy Only the User has access to their password. No other User may see or have access to the User’s password. © ImpediMed – April 2019 Page 34 LBL-537-en REV B...
Page 35: Password Reset
6.2.2 Password Reset If you have trouble logging in or forget your password, click the message below the Login button. On the next screen, enter email address for the MySOZO account. © ImpediMed – April 2019 Page 35 LBL-537-en REV B...
Page 36 A pop-up notifies the User to expect a password reset email from ImpediMed. After ImpediMed sends the email with password reset instructions, click Reset Password link in the email. Create and confirm the new password on the “Set New Password” screen.
Page 37: Password Expiration
6.2.3 Password Expiration Your password will expire within a time period set by your Clinic. A pop-up will warn you about upcoming password expiration. To reset your password, click Reset Now. © ImpediMed – April 2019 Page 37 LBL-537-en REV B...
Page 38: Mysozo Administrator
6.3 MySOZO Administrator An Administrator has exclusive authority to manage MySOZO User accounts, adjust certain SOZO system-wide settings and export Audit Logs. The Clinic sets up ImpediMed Administrator accounts. Administrators are identified by their email address. 6.3.1 Administrator Home Page...
Page 39: Logged In Status
6.3.2.2 Profile of Administrator Logged into MySOZO User Profile Icon The name of the User logged into MySOZO appears next to the User Profile icon. To review or edit the User profile, click User Profile icon. © ImpediMed – April 2019 Page 39 LBL-537-en REV B...
Page 40: User List
6.3.2.3 User List User List Icon Click User List icon at any time to return to the User List on the MySOZO Administrator home page. © ImpediMed – April 2019 Page 40 LBL-537-en REV B...
Page 41: Help
6.3.2.4 Help Help Icon For assistance with use of MySOZO, click the question mark, which is the Help icon. The Help page includes contact information for ImpediMed technical support and product Information. 6.3.2.5 Log Out Log Out Icon To log out of MySOZO at any time, click Log Out icon on the upper right.
Page 42: Mysozo Main Menu
On the “User Details” screen, enter the User’s first name, last name and email address. The remaining fields, including middle name, country code and phone number, are optional. Under “User Role,” select Administrator or Clinician. When done, click Create User. © ImpediMed – April 2019 Page 42 LBL-537-en REV B...
Page 43 User as” an Administrator with one email address. Then, for the same person, create a second User as the Clinician, and assign a different email address to the Clinician. © ImpediMed – April 2019 Page 43 LBL-537-en REV B...
Page 44: Edit User Profile
6.3.3.3 Delete User To delete a User, on the “User List” Administrator home page, select the box next to the User to be deleted and click Delete User tab. © ImpediMed – April 2019 Page 44 LBL-537-en REV B...
Page 45 Click Yes in the Warning pop-up. MySOZO confirms deletion of the User. Click OK. © ImpediMed – April 2019 Page 45 LBL-537-en REV B...
Page 46: Restore User
To restore a deleted User: 6.3.3.4.1 Click Settings Tab 6.3.3.4.2 Click Restore User On the “Security Settings” screen, scroll mouse down to the bottom and click Restore User. © ImpediMed – April 2019 Page 46 LBL-537-en REV B...
Page 47 6.3.3.4.3 Click Restore Under “Deleted Users” screen, select the User to restore and click Restore. Click Yes on Warning. © ImpediMed – April 2019 Page 47 LBL-537-en REV B...
Page 48: Export Audit Logs
MySOZO pages or information, identity of Users who have retrieved data, and Users’ log in and log out dates and times. To export audit logs, click Export Audit Logs tab. © ImpediMed – April 2019 Page 48 LBL-537-en REV B...
Page 49 Enter the date range in the “Export Audit Logs (CSV)” pop-up and click Export. This will trigger a pop-up about the export process. Click OK. ImpediMed will send the User an email with a secure link to download data, which is valid for 48 hours.
Page 50: Settings
6.3.3.6 Settings Settings is the last tab on the MySOZO Administrator Main Menu. © ImpediMed – April 2019 Page 50 LBL-537-en REV B...
Page 51 On the “Security Settings” screen, scroll down to change the system-wide settings, which includes password policy, password expiration period, time zone, logout inactivity time, and licences. When finished, click Save. © ImpediMed – April 2019 Page 51 LBL-537-en REV B...
Page 52: Mysozo Clinician
Login leads to the MySOZO Clinician home page, with the “Patient List.” To search for a patient, enter the name of the patient in the Search Patient field and click the Search icon. © ImpediMed – April 2019 Page 52 LBL-537-en REV B...
Page 53: Banner Icons
6.4.3.1 Patient List Icon The Patient List Icon is a shortcut to the Patient List. 6.4.3.2 Help (Question Mark) Icon Click the question mark icon for help. 6.4.3.3 Log Out Icon © ImpediMed – April 2019 Page 53 LBL-537-en REV B...
Page 54: Clinician Main Menu
The Patient Dashboard has detailed information about each patient. To go to the Patient Dashboard, select a patient from the “Patient List.” Click Patient Dashboard tab. The “Patient Details” screen appears. © ImpediMed – April 2019 Page 54 LBL-537-en REV B...
Page 55: Create Patient
“Patient Details” shows the date of the patient’s last Assessment and the types of Assessments available. 6.4.4.2 Create Patient The Clinician may create a patient in MySOZO by clicking Create Patient tab, which leads to “Patient Details.” © ImpediMed – April 2019 Page 55 LBL-537-en REV B...
Page 56 Not Provided box under the Email Address field. Scroll down the “Patient Details” page to view “Type of Assessment” and “Lymphoedema Settings.” When done, click Create Patient. © ImpediMed – April 2019 Page 56 LBL-537-en REV B...
Page 57: Delete Patient
ImpediMed Technical Support. 6.4.4.4 Restore Patient To restore a deleted patient, click Settings tab on the Clinician Main Menu. At the bottom of the “Settings” screen, next to “Restore Patient,” click Restore. © ImpediMed – April 2019 Page 57 LBL-537-en REV B...
Page 58: Export
A Clinician may not export data from the SOZOapp. To export data, click Export tab. A pop-up displays export settings, which includes Assessment types, date range and data format. When finished, click Export. © ImpediMed – April 2019 Page 58 LBL-537-en REV B...
Page 59 Clicking Export triggers a pop-up on the downloading process. Review the instructions and click OK. 63/169) © ImpediMed – April 2019 Page 59 LBL-537-en REV B...
Page 60: Patient Report: Report/Print
Patient) and adjust the measurement units. Under “Measurement Units,” the Restore Clinician may adjust the measurement standard as: kg or lbs, centimetres or inches, and litres or pints. When finished, click Save. © ImpediMed – April 2019 Page 60 LBL-537-en REV B...
Page 61: Patient Dashboard
6.4.5 Patient Dashboard Selecting a patient from the Patient List, per Section 6.4.4.1 Patient Dashboard, leads to the Patient Dashboard home page, “Patient Details.” © ImpediMed – April 2019 Page 61 LBL-537-en REV B...
Page 62: Introduction To Patient Dashboard
History tab to see “Patient Details.” Beneath “History” is a list of Assessments. Click each Assessment to view a graph of the history of patient measurements. A blue line shows which Assessment was selected. © ImpediMed – April 2019 Page 62 LBL-537-en REV B...
Page 64 6.4.5.2.1 Setting a Baseline The Clinician may set or remove a measurement baseline for each Assessment type. “No Baseline” appears next to Set Baseline if no measurement is chosen as the baseline. © ImpediMed – April 2019 Page 64 LBL-537-en REV B...
Page 65 After setting the baseline, the Clinician may compare patient measurements taken over time against the baseline. From this comparison, the Clinician may identify changes in patient fluid levels, and see if these changes fall within normal or abnormal ranges. © ImpediMed – April 2019 Page 65 LBL-537-en REV B...
Page 66 6.4.5.2.3 Examples of History of Measurements Below are examples of measurement history for L-Dex, Fluid Analysis and Tissue Analysis. 6.4.5.2.3.1 Example of L-Dex History in MySOZO © ImpediMed – April 2019 Page 66 LBL-537-en REV B...
Page 67 Roll mouse over any data point on the history graph to display the measurement. © ImpediMed – April 2019 Page 67 LBL-537-en REV B...
Page 70: Measurement Results Viewable By Clinician In Mysozo
Select a date under “Select Measurement Date.” The results screen appears. Some results may have additional breakdowns of Assessment-specific data. Below are results examples for L-Dex, Fluid Analysis, Tissue Analysis and Cole plots. © ImpediMed – April 2019 Page 70 LBL-537-en REV B...
Page 74 Assessment-specific charts, such as a weight breakdown chart for Tissue Analysis, may be displayed, as shown below. 6.4.5.3.3.1 Example of Tissue Analysis Weight Breakdown Chart in MySOZO © ImpediMed – April 2019 Page 74 LBL-537-en REV B...
Page 75 6.4.5.3.4 Example of Cole Plots in MySOZO The SOZO software helps determine the quality of the Cole plots as high quality (green), medium quality (yellow) or low quality (red). © ImpediMed – April 2019 Page 75 LBL-537-en REV B...
Page 76: Edit Patient Profile
For more about reviewing Cole plots in the SOZOapp, see Section 8.6.2.4 Reviewing Cole Plots After Measurement. 6.4.5.4 Edit Patient Profile To edit a patient profile in MySOZO, click Edit Profile tab on the Patient Dashboard. © ImpediMed – April 2019 Page 76 LBL-537-en REV B...
Page 77 The “Patient Details” screen displays patient personal information, Assessment types and other settings. When done, click Save Changes at the bottom of the screen. © ImpediMed – April 2019 Page 77 LBL-537-en REV B...
Page 78: Patient Report: Report/Print
Instructions for Use; Fluid Analysis in Section 9.3.2.2 Instructions for Use; and Tissue Analysis in Section 9.3.3.2 Instructions for Use. For more about Assessments, see Section 9.0 Assessments. 6.4.5.5 Patient Report: Report/Print © ImpediMed – April 2019 Page 78 LBL-537-en REV B...
Page 79 The Clinician may create a patient report in MySOZO by clicking Report/Print tab on the Patient Dashboard. The report may be customized by measurement type, history graphs and date range. When done, click Create Report. © ImpediMed – April 2019 Page 79 LBL-537-en REV B...
Page 80: Preparing The Patient
7.1 Introduction 7.1.1 Preparing for All Measurements The Clinician taking measurements on a SOZO Device must make sure that the patient: (1) Removes all metal jewellery if possible, including large belt buckles; Items above the neck such as earrings are okay.
Page 81: Standing Vs. Seated Position
7.2 Standing vs. Seated Position The SOZO system is designed to accommodate patients who may not be able to stand, or who may exceed the maximum weight limitation (up to 375lbs if patient is standing, and up to 750 lbs if patient is sitting). See instructions for system configuration for standing, 5.1 SOZO Device with SOZOsupport...
Page 82: Seated Position
Sit fully upright and balanced in the chair with shoulders rolled back. • Distribute body weight evenly on both hips. • Bend the knees at a right angle, plus or minus 10 degrees. © ImpediMed – April 2019 Page 82 LBL-537-en REV B...
Page 83: Using The Sozoapp
8.0 Using the SOZOapp 8.1 Introduction Clinicians may access the SOZO system through MySOZO and the SOZOapp. The SOZOapp allows Clinicians to conduct most SOZO functions, including: 1) Management of patient profiles, including adding, editing or selecting patients from a patient list;...
Page 84: Selecting Sozo Device
Type the patient’s name into Search Patient field. A search may be done using the sort feature. Tap the Sort icon and select criteria for sorting, which are ascending or descending order, date of birth, sex, MRN or last SOZO Assessment. 8.4 Selecting SOZO Device.
Page 85: Enter Email Address
On the Tablet, tap the SOZOapp. If, for any reason, the SOZOapp has been deleted, contact ImpediMed for re-installation. As newer SOZOapp versions are released, the appearance of the SOZOapp icon may change. 8.2.3 Enter Email Address Under “Log in to Your Account,” enter password, select language and tap Log In.
Page 86: Sozoapp Home Screen
If you have trouble logging in, you may reset your password by clicking the “Having Trouble” message under Log In. ImpediMed will send you an email with a password reset link, which will bring you to the “Set New Password” screen. From the “Set New Password” screen, enter your new password and tap Submit.
Page 87: User Profile Icon
Next, on the “My Profile” screen, review, edit and tap Save. 8.3.1.2 Log Out The User may log out by tapping the Log Out icon. 8.3.1.3 Patient List The patient list is on the home screen. © ImpediMed – April 2019 Page 87 LBL-537-en REV B...
Page 88: Conducting Patient Search
Type the patient’s name into Search Patient field. A search may be done using the sort feature. Tap the Sort icon and select criteria for sorting, which are ascending or descending order, date of birth, sex, MRN or last SOZO Assessment. ©...
Page 89: Selecting Sozo Device
SOZOtouch housing, SOZOstep housing, and the SOZOconnect Cable. The process may be repeated for any new SOZO Devices and must be repeated if either the Tablet or system are replaced. The SOZOapp may only select and work with one SOZO Device at a time.
Page 90: Confirming Sozo Device Status
8.4.1 Confirming SOZO Device Status The User should confirm connection to the correct SOZO Device. Confirmation may be done in Settings, or by a self-test. 8.4.1.1 Using Settings to Confirm Device Status To confirm SOZO Device status, tap the Settings tab.
Page 91: Using The Self-Test To Confirm Device Status
8.4.1.2 Using the Self-Test to Confirm Device Status The status of the SOZO Device may also be confirmed by a self-test. To run the self- test, tap the Self-Test tab from the SOZOapp Main Menu. If the SOZO Device emits a clicking sound, and the Self-Test is shown as successful, the Device Status is confirmed.
Page 92: Assessment Type
The Clinician has the sole authority to create and edit patient profile information. 8.5.1.2 Assessment Type Scroll down the “Create Patient” page for a list of types of Assessments which apply to the patient. © ImpediMed – April 2019 Page 92 LBL-537-en REV B...
Page 93: Lymphoedema Settings
A patient may only be deleted by the Clinician from MySOZO. See MySOZO Section 6.4.4.3 Delete Patient. 8.5.3 Restore Patient The Clinician may restore a deleted patient by tapping the Settings tab. © ImpediMed – April 2019 Page 93 LBL-537-en REV B...
Page 94 On the “Settings” page, scroll down and tap Restore Patient. From the “Deleted Patients List,” select the patient to restore. On the Caution pop-up, tap Restore Patient. © ImpediMed – April 2019 Page 94 LBL-537-en REV B...
Page 95: Pairing Sozo Device
8.5.4 Pairing SOZO Device The Pairing Device tab on the SOZOapp Main Menu is a shortcut to pairing the SOZO Device with the Tablet, usually during initial set-up. To review the steps for pairing, go to Section 8.2.1 Pairing the Tablet with the SOZO Device.
Page 96: Adjusting Units Of Measure
Under Settings, the measurement standard for weight, height and water volume may be converted to the preferable standard of the User. Kilograms may be converted to pounds, centimetres to inches and litres to pints. When done, tap Save. © ImpediMed – April 2019 Page 96 LBL-537-en REV B...
Page 97: Firmware Update
8.5.5.2 Firmware Update The SOZO Device software, or “firmware,” may be updated by tapping Update next to “Firmware Update.” © ImpediMed – April 2019 Page 97 LBL-537-en REV B...
Page 98: Licencing Status
8.5.5.2 Licencing Status By tapping the View button, the Clinician may view, but not change, the Clinic’s licencing status for various Assessments offered to ImpediMed customers. 8.5.5.3 Check SOZOapp Version The User will be notified at log in if a newer SOZOapp version is available. The User may confirm their SOZOapp version under “Application Version”...
Page 99: Taking Measurements
The SOZOapp will always be the most compatible version with the SOZO system. If the SOZOapp version is not the most current version, it will be automatically updated. 8.6 Taking Measurements The SOZO Device supports various types of measurements for each Assessment, such as measurements for the detection of lymphoedema, for monitoring of fluid, and for different body composition outputs.
Page 100: Select Patient From Patient List
8.6.2.1 Self-Test To ensure measurement accuracy, the Clinician must run a self-test before beginning any measurements. Tap Self-Test tab on the Patient Dashboard, review the self-test instructions and tap Begin Self-Test. © ImpediMed – April 2019 Page 100 LBL-537-en REV B...
Page 101: Preparing To Take Measurements
The Clinician must follow the below steps before starting a measurement. Tap Measure tab on the Patient Dashboard. To ensure patient privacy, do not permit the patient to handle the Tablet while taking SOZO measurements. © ImpediMed – April 2019...
Page 102 8.6.2.2.2 Entering Weight The Clinician enters the patient’s current weight prior to each measurement session. Accurate weight entry is critical to tissue and fluid analysis. The patient should be weighed immediately prior to the SOZO measurement. © ImpediMed – April 2019...
Page 103 There are two electrode plates for the left foot, and two electrode plates for the right foot. © ImpediMed – April 2019 Page 103 LBL-537-en REV B...
Page 104 Make sure each hand is flat and in full contact with each electrode plate. There are two electrode plates for the left hand, and two electrode plates for the right hand. © ImpediMed – April 2019 Page 104 LBL-537-en REV B...
Page 105: Start Measurement
Surface temperature should not exceed 47° C (117° F) during normal use. Do not use SOZO Device if it is hot to the touch. Disconnect the SOZO Device by unplugging the Power Adaptor and call ImpediMed Technical Support. Read Intended Use and Precautions before taking measurements with the SOZO Device.
Page 106 The measurement will cancel if no contact is detected. 8.6.2.3.1 Measurement Duration Once started, the SOZO Device measurement will take approximately 20 seconds. The measurement in progress window remains until the measurement is complete. ©...
Page 107 The SOZO Device makes audible clicking noises during measurement. These clicking noises indicate that the process is working correctly. 8.6.2.3.2 Losing Connectivity During Measurement If you lose connectivity while the Measurement is in progress, follow troubleshooting tips in Troubleshooting Section 10.1.4 Losing Connectivity During Measurement.
Page 108: Reviewing Cole Plots After Measurement
8.6.2.4.1 Considering Cole Plots in Deciding to Accept or Reject Measurements The SOZO software helps determine the quality of measurements by ranking each Cole plot as “High Quality” (green), “Medium Quality” (yellow) or “Low Quality” (red), as shown below.
Page 109 Determination of the quality of a given measurement can only be made at the time of measurement, but Cole plots are also shown when reviewing historical results. © ImpediMed – April 2019 Page 109 LBL-537-en REV B...
Page 110: History
Tap each Assessment to see historical measurements. Only historical measurements for licenced Assessments will appear under History. Therefore, the Clinician will only be able to view licenced Assessments. © ImpediMed – April 2019 Page 110 LBL-537-en REV B...
Page 111 8.6.2.5.1 Examples of Historical Measurements Below are examples of historical measurements for L-Dex, Fluid Analysis and Tissue Analysis. 8.6.2.5.1.1 Example of L-Dex History in SOZOapp © ImpediMed – April 2019 Page 111 LBL-537-en REV B...
Page 113 Section 6.4.5.2.1 Setting a Baseline. For more information on how a baseline is relevant to ® each Assessment, see Sections 9.3.1 L-Dex Lymphoedema, 9.3.2 Fluid Analysis and 9.3.3 Tissue Analysis. © ImpediMed – April 2019 Page 113 LBL-537-en REV B...
Page 114: Results
For an L-Dex Assessment, this is accompanied by historical trends for the patient. The results page has graphs on selected Assessment types and Cole plots. Examples are shown below. © ImpediMed – April 2019 Page 114 LBL-537-en REV B...
Page 119: Edit Patient Profile
Section 6.4.5.2 Measurement History 8.6.2.6.5 Impact of Licencing Additional Assessments on Results When the SOZO Device takes measurements, it collects and stores bioimpedance data categorized by date and time. These are independent of the type of Assessment. If the Clinic decides to purchase additional Assessment licences, the new Assessments may be added to a patient’s history.
Page 120 Once all changes are made to the patient profile, tap Save on upper right. If an email address is not provided, leave the email field blank and tap the “Not Provided” box. © ImpediMed – April 2019 Page 120 LBL-537-en REV B...
Page 121 L-Dex data (at-risk limb, dominant limb) is shown in the patient profile when the L-Dex Assessment is selected. Please note that deselecting the L-Dex Assessment will grey out the patient L-Dex settings, which will not be saved. © ImpediMed – April 2019 Page 121 LBL-537-en REV B...
Page 122: Assessments
9.0 Assessments 9.1 Introduction to Assessments The SOZO Device supports the following types of Assessments: 1) L-Dex; 2) Fluid Monitoring & Analysis; and 3) Tissue Analysis Depending on licencing, all Assessments and measurements may or may not be available or in MySOZO and the SOZOapp.
Page 123: Instructions For Use
9.3.1.3 The Lymphoedema Index (L-Dex) The SOZO system displays L-Dex Assessment results based upon patient measurements taken with the SOZO Device. The L-Dex Assessment produces an L- Dex score, which is based on the ratio of the impedance of the unaffected limb(s) to impedance of the at-risk limb(s).
Page 124: L-Dex Assessment Results
ROC curve (AUC) is a measure of how well a parameter can distinguish between two groups (diseased/normal). The closer the modelled AUC comes to 1, the better it is. SOZO’s L-Dex® accuracy was calculated with an area under the curve (AUC) of 0.95 for unilateral assessment and 0.80 for bilateral assessment.
Page 125: Availability Of L-Dex Assessment
Results Trends 9.3.1.7 History of Measurements and In addition to the results display screen, the SOZO system also provides a history of patient measurements in graph format, to allow comparison between current results and previous results. This shows increases or decreases in the L-Dex score over time. For more about the...
Page 126: Recommended Measurement Frequency For L-Dex
If a patient has already developed lymphoedema and SOZO is being used to track their progress, do not set the baseline, as it will cause confusion with the modified red/yellow/green ranges.
Page 127: Fluid Analysis Results
• Intracellular Fluid (ICF); • TBW as a percentage of weight; and • ECF and ICF distribution (expressed as a percentage of total body water). • Hydration Index (Hy-Dex) Analysis © ImpediMed – April 2019 Page 127 LBL-537-en REV B...
Page 128: Recommended Measurement Frequency For Fluid Analysis
Phase Angle (Phi) • Body Mass Index (BMI) The SOZO Device measures current, voltage and phase angle (Phi), and from these values calculates resistance (R), reactance (Xc), and impedance (Z), which are used to estimate the above body composition parameters.
Page 129: Tissue Analysis Results
9.3.3.3 Tissue Analysis Results At the conclusion of a SOZO device measurement, the SOZOapp displays results of the Tissue Analysis Assessment. The Tissue Analysis Assessment contains graphs and a wide range of body composition information in preferred units of measure.
Page 130: Troubleshooting
• Reset the Bluetooth® button on the back of SOZOtouch • Unplug the SOZO Device from the wall outlet and plug back in 10.1.2 Patient Profile 10.1.2.1 Assessment Type After tapping Edit Profile tab on Patient Dashboard, changing the Assessment type may trigger an error message.
Page 131 “The patient has no assessment type selected or current licencing status does not allow taking a measurement.” 10.1.2.1.2 Resolution Tap Edit Profile tab on Patient Dashboard. © ImpediMed –May 2019 Page 131 LBL-537-en REV B...
Page 132: Lymphoedema Settings
Choose Assessment Type under “Patient Details.” 10.1.2.2 Lymphoedema Settings Editing Lymphoedema Settings on the patient profile may trigger an error message. © ImpediMed –May 2019 Page 132 LBL-537-en REV B...
Page 133: Patient Dashboard
If “Bilateral” is selected as the “Assessment Type,” after arm or leg is chosen as the “Body Element,” “Left and “Right” are both automatically selected as “Risk Limb.” 10.1.3 Patient Dashboard After starting measurement, an error message may appear on the Patient Dashboard. © ImpediMed –May 2019 Page 133 LBL-537-en REV B...
Page 134: Error Message
10.1.3.1 Error Message “Something Went Wrong. Measurement not started because the electrode check failed.” 10.1.3.2 Resolution Ensure that the patient is standing on the SOZO Device before tapping Measure. © ImpediMed –May 2019 Page 134 LBL-537-en REV B...
Page 135: Losing Connectivity During Measurement
Start Measurement. 10.2 General Troubleshooting Chart The General Troubleshooting chart provides guidance for common issues and error messages. In the event that you need additional help, call 877 247-0111, ImpediMed technical support, or you may email ImpediMed at tsu@impedimed.com or visit https://www.impedimed.com.
Page 136 SOZO hardware does not emit Power cord not properly connected Confirm power cord is properly audible clicks when powering on; or potential hardware failure. connected. If cord is correctly LED at back of unit is not emitting a inserted, contact ImpediMed blue light.
Page 137 Error in sending data from SOZO Take another measurement. Move Check your internet connection or hardware to Tablet. Potential issue location of SOZO Device if it is in contact ImpediMed Technical with disruption of Bluetooth signal. an area with other equipment that Support.”...
Page 138 Confirm Tablet Bluetooth is turned problem” off. on. Turn off and restart the Tablet and the SOZO Device. Press the Bluetooth reset button on the back of the SOZOtouch panel and verify blue light at back of unit is illuminated. If Bluetooth is enabled...
Page 139 Clinic IT Administrator Interfacing with SOZO System Issue/Error Message Potential Cause Resolution “The email entered already exists When creating a new clinician, the Use different username/email. for another clinician or selected username is identical to an administrator. The email used must existing username/email.
Page 140: Personal Data
11.0 Personal Data Read our privacy policy located at https://www.impedimed.com/privacy-policy/ © ImpediMed –May 2019 Page 140 LBL-537-en REV B...
Page 141: Care And Maintenance
12.1 The SOZO Device 12.1.1 Care When not in use, the SOZO Device may remain set up and does not need to be uninstalled. If storage is desired, always keep the SOZO Device in its original packaging. The external enclosure of the SOZO Device should be cleaned between each use with non- ®...
Page 142: Repairs
There are no user-repairable electronic parts within the SOZO Device. Contact ImpediMed or an authorized agent should service or repair of the SOZO Device be required. Do not attempt to use the SOZO Device if it does not appear to be functioning correctly or needs repair. 12.4 Tablet Maintenance The Samsung SM-T580 Tablet is shipped partially charged and will need to be charged periodically throughout its use.
Page 143: Components And Accessories
12.5 Technical Support The following components and accessories are available for separate purchase. Please contact ImpediMed or an authorized agent to purchase replacement parts. Description SOZOsupport Stand SOZOconnect Cable Power Supply Cable Tablet Tablet Sleeves © ImpediMed –May 2019 Page 143...
Page 144: Impedimed Product Warranty
13.0 ImpediMed Product Warranty ImpediMed warrants to the purchaser that in the event of product failure under normal use, due to defects in material or workmanship within the specified period(s) listed below, the device and accessories will be repaired, or at ImpediMed’s option, replaced. The device and accessories are to be returned to ImpediMed, accompanied by proof of purchase, your name, your return address and a statement of the defect.
Page 145: Regulatory Statement
Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) This device must accept any interference received, including interference that may cause undesired operation. This device complies with the R&TTE Directive. © ImpediMed –May 2019 Page 145 LBL-537-en REV B...
Page 146: Product Specifications
Hand Plate L=330mm, W=180mm, D=170mm Foot Plate L=450mm, W=320mm, D=40mm Effective Radiated Power -18 dBW (BT Module) Weight SOZO Device: 10.0 lb/4.5 kg SOZOsupport Stand: 25.5 lb/11.6 kg Data Displayed Cole resistance-reactance plot, other outputs dependent on measurement module. Environmental transport, - 25 °C without relative humidity control;...
Page 147: Safety And Electromagnetic Compatibility (Emc) Information
Compatibility (EMC) Information Guidance and manufacturer’s declaration – electromagnetic emissions The SOZO device is intended for use in the electromagnetic environment specified below. The customer or the user of the SOZO device should assure that it is used in such an environment.
Page 148 NOTE Ur is the AC mains voltage prior to application of the test level. Guidance and Manufacturer’s Declaration – Immunity The SOZO device is intended for use in the electromagnetic environment specified below. The customer or the user of the SOZO device should assure that it is used in such an environment.
Page 149 1,3,4,25; UMTS 1 970 Bluetooth, WLAN, Pulse 2400- 2450 802.11 b/g/n, Modulation 2570 RFID 2450, 217 Hz LTE Band 7 5240 Pulse 5100- WLAN 802.11 5500 Modulation 5800 217 Hz 5785 © ImpediMed –May 2019 Page 149 LBL-537-en REV B...
Page 150 SOZO device The SOZO device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the SOZO device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the SOZO device as recommended below, according to the maximum output power of the communications equipment.
Page 151: Index
Availability in geographic regions, 122 Placement tutorial, SOZOapp, 103 Choosing for the patient, 122 Footplate Selecting based on individual patients, 121 For assembly of SOZO Device, 25 Types, MySOZO Clinician, 56 SOZO system hardware, 17 Types, SOZOapp, 92 Audit Logs...
Page 152 Mozilla Firefox SOZO system hardware, 17 Web browser, user device internet requirements for Power Cord MySOZO, 8 Assembly of SOZO Device, 29 MySOZO Power Supply FIrst time set-up, all users, 33, 52 Assembly of SOZO Device, 32 Icons, MySOZO Clinician, 53...
Page 153 Run from SOZOapp Patient Dashboard, 100 Tablet Use for SOZO Device confirmation, 95 Function in SOZO System, 8 Use to confirm SOZO Device status, SOZOapp, 91, 95 Maintentance, 142 When to run, 141 Settings Pairing with SOZO Device, 83, 95...
Page 154 Warnings Pregnant patients, 20 Warranty Product, 147 Weight Breakdown chart, MySOZO tissue analysis, 74 Patient, entry of, SOZOapp, 104 Patient, modification of, 79 Tissue analysis breakdown chart, in MySOZO, 74 © ImpediMed –May 2019 Page 154 LBL-537-en REV B...

ImpediMed SOZO Instructions For Use Manual

1 Minimum Requirements

2 Glossary

3 Introduction to the SOZO System

4 Safety Instructions

5 SOZO Device Assembly

6 Mysozo

7 Preparing the Patient

8 Using the Sozoapp

9 Assessments

10 Troubleshooting

11 Personal Data

12 Care and Maintenance

13 Impedimed Product Warranty

14 Regulatory Statement

15 Product Specifications

16 Safety and Electromagnetic Compatibility (EMC) Information

17 Index

Quick Links

Troubleshooting

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Summary of Contents for ImpediMed SOZO

Table of Contents